(107 days)
No
The device description and performance studies focus on mechanical properties and surgical application, with no mention of AI/ML terms or functionalities.
No
The device is a screw used for bone fixation and reconstruction, which is a structural implant rather than a device designed to provide therapy.
No
Explanation: The device is described as a "Twist off Screw" intended for "Fixation of fracture, fusion of a joint or bone reconstruction". This indicates a therapeutic or surgical purpose, not a diagnostic one.
No
The device description explicitly states it is a physical screw made of titanium alloy, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states the device is a "Twist off Screw" made of titanium alloy, intended for "Fixation of fracture, fusion of a joint or bone reconstruction (osteotomy) of the phalanges, metacarpals and carpals of the hand." This is a surgical implant used directly on the bone.
- Intended Use: The intended use is for surgical procedures to stabilize and repair bones, not to analyze biological samples.
The information provided describes a surgical orthopedic device, not an IVD.
N/A
Intended Use / Indications for Use
This screw is to be implanted for the fixation of fracture, fusion of a joint or bone reconstruction of the carpals, metacarpals and phalanges of the hand.
Fixation of fracture, fusion of a joint or bone reconstruction (osteotomy) of the phalanges, metacarpals and carpals of the hand.
Product codes
87HWC
Device Description
The Twist off Screw is made of titanium alloy and consists of a screw integrated with separates from the screw when the head meets cortical bone. It is 2.0mm in diameter and 11 to 14mm in length and has a selftapping tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
carpals, metacarpals, phalanges of the hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing of the Twist-off Screw was performed for the K962233. The maximum torque at rupture for the separation of the holder and the screw averages 0.17Nm and the maximum lorque for rupture of the Twist-off Screw averages 0.37Nm.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
SUMMARY OF SAFETY AND EFFECTIVENESS
| MANUFACTURER IDENTIFICATION: | Medinov-AMP
27 à 31 rue Lucien Langenieux
42335 Roanne FRANCE | |
|------------------------------------------------------|---------------------------------------------------------------------------------------------|--------------|
| ESTABLISHMENT REGISTRATION
NUMBER (Manufacturer): | 9681744 | JUL - 9 1997 |
| SPONSOR IDENTIFICATION: | Cheryl Hastings
DePuy, Inc.
P.O. Box 988
700 Orthopaedic Drive
Warsaw, IN 46580 | |
| ESTABLISHMENT REGISTRATION
NUMBER (Sponsor): | 1818910 | |
| PROPRIETARY NAME: | Twist-off tm Screw | |
| PRODUCT CLASSIFICATION CODE: | 87HWC | |
| PROPOSED REGULATORY CLASS: | Class II | |
DESCRIPTION:
The Twist off Screw is made of titanium alloy and consists of a screw integrated with separates from the screw when the head meets cortical bone. It is 2.0mm in diameter and 11 to 14mm in length and has a selftapping tip.
INDICATIONS AND INTENDED USE:
This screw is to be implanted for the fixation of fracture, fusion of a joint or bone reconstruction of the carpals, metacarpals and phalanges of the hand.
PREDICATE DEVICES:
The predicate devices for this screw are the Landos Twist-off" Screw, the Howmedica Lubr Screw System, the Synthes Cortex Screw and the Osteomed M3 Screw.
TESTING:
Testing of the Twist-off Screw was performed for the K962233. The maximum torque at rupture for the separation of the holder and the screw averages 0.17Nm and the maximum lorque for rupture of the Twist-off Screw averages 0.37Nm.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, services, and the well-being of the American people. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUM. SERVICES USA" in a circular arrangement.
JUL - 9 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Cheryl Hastings ·DePuy, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
Re : K971069 Twist-off™ Screw Requlatory Class: II Product Code: HWC May 30, 1997 Dated: Received: June 2, 1997
Dear Ms. Hastings:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act .
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Note that labeling or otherwise promoting a device for pedicular screw fixation/attachment would cause the device to be adulterated under 501(f)(1) of the Act. This device, if intended for use in pedicular screw fixation/attachment, would be found not substantially equivalent and would be a class III device under Section 513(f) Class III devices are required to have an approved of the Act. premarket approval (FMA) application prior to marketing. Accordingly:
- The package insert must prominently state that the device 1. is intended for the specific use(s) described in the enclosure only; and
- You may not label or in any way promote this device for 2. pedicular screw attachment to, or fixation of the cervical, thoracic or lumbar vertebral column. If this
2
device is a screw with outer diameters of 3 mm - 10 mm and overall lengths of 10 mm - 75 mm inclusively, the package insert must include the following statement, This device is not approved for screw "WARNING: attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine." Any pedicular screw fixation/attachment to the cervical, thoracic or lumbar vertebral column of this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulations under 21 CFR, Part 812. All users of the device for pedicular screw fixation/attachment must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conduct of the investigation.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket
3
Page 3 - Cheryl Hastings
notification" (21 CFR 807.97). Other general information on nocrited. (a) order the Act may be obtained from the your responsibiliti Division of Omari Nanaracourt (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
-
cole
-
Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
| 510(k) Number (if known): | K971069 |
|---|---|
| Device Name: | Twist-off Screw |
| Indications for Use: |
Fixation of fracture, fusion of a joint or bone reconstruction (osteotomy) of the phalanges, metacarpals and carpals of the hand.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices, 1971069
510(k) Number.
Prescription Use
(Per 21 CFR 801.109) X
OR
Over-the-Counter Use
(Optional Format 1-2-96)